This course teaches the key principles and practices of effective quality management system audits in accordance with ISO 13485:2016 and ISO 19011, “Guidelines for auditing management systems”. Experienced instructors guide students through the entire audit process, from managing an audit programme to reporting on audit results. Participants will gain the knowledge and skills to plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance.
Who should attend?
- Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
- Management representatives
- Quality directors, managers, and engineers
Do you already have a good knowledge of ISO 13485:2016?
If not, we highly recommend you take our ISO 13485:2016 Clause by Clause training course first as there are particular requirements you need to understand before you can be an auditor.
What will I learn?
On completion of this training, participants will be able to:
- Gain the skills to plan, conduct, report and follow up an audit in accordance with ISO 19011
- Identify the purpose and benefits of an ISO 13485:2016 QMS
- Explain the role of an auditor in planning, conducting, reporting and following up an audit in accordance with ISO 19011 (and ISO 17021 where appropriate)
How will I benefit?
- Identify the aims and benefits of an ISO 13485:2016 audit
- Interpret ISO 13485:2016 requirements for audit application
- Plan, conduct and follow-up auditing activities that add real value
- Grasp the application of risk-based thinking, leadership and process management
- Access the latest auditor techniques and identify appropriate use
- Build stakeholder confidence by managing processes in line with the latest requirements
- Understand the arrangements for BSI certification
The residential and non-residential courses both include:
- You will gain 40 CPD points on completing the course
- Course notes
The residential option also includes 4 nights accommodation and evening meals from the first day of the course.
Additional course options
Discover our ISO 13485 Qualifications - Our ISO 13485 auditor qualifications will give you a BSI Mark of Trust, reassuring your customers and suppliers that your skills have been validated. You can achieve Practitioner or Professional status by successfully completing courses, exams and demonstrating practical application. Find out more